MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELREPLACE CC PMC RP 5.0X10MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37296
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Failure of Implant (1924)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to abscess.

• Brand Name: NOBELREPLACE CC PMC RP 5.0X10MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer (Section G): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 20325763
• Report Number: 2027971-2024-127838
• Device Sequence Number: 20869811
• Product Code: DZE
• UDI-Device Identifier: 07332747073539
• UDI-Public: (01)07332747073539(10)13052536(17)220825
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2022
• Device Catalogue Number: 37296
• Device Lot Number: 13052536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male